EAL

DM: Effectiveness of MNT Provided by RD/RDN (2015)

Citation:

Study Design:

Class:

- Click here for explanation of classification scheme.

Quality Rating:

Research Purpose:

To examine the effects of intensified dietary therapy on food consumption patterns, energy and nutrient intakes, and the fatty acid composition of serum triglycerides, phospholipids, and cholesterol esters in patients with recently diagnosed type 2 diabetes, and to determine how well the main goals of dietary recommendations are met by patients with recently diagnosed NIDDM.

Inclusion Criteria:

40-69 yrs of age
Newly diagnosed type 2 diabetes mellitus
FBG >6.7 mmol/L in repeated measurements

Exclusion Criteria:

None specifically mentioned.

Description of Study Protocol:

Recruitment

Physicians working in 5 rural and 1 urban (Kuopio) health centers were asked to refer all patients with newly diagnosed type 2 diabetes mellitus to the Kuopio University Hospital (Finland) outpatient clinic.

108 patients were recruited.

Design

Baseline: at 0 month, 6 wk and 3 mo, all subjects received basic education from a physician and diabetes nurse specialist (causes of diabetes, treatment of diabetes, complications of diabetes; advised to increase physical activity and to restrict kcal, fat, cholesterol and saturated fat).

3 months: Subjects were randomized into conventional or intervention groups

Intervention

Conventional: follow-up in local health clinics q 2-3 mos for usual education.

Also, visited Kuopio outpatient clinic at 9 and 15 months.

Intervention: Kuopio clinic q 2 mos (total 6 times) for education by the physician, diabetes nurse and clinical nutritionist.

Blinding Used (if applicable): none

Statistical Analysis

Multivariate analysis of variance for a repeated measures design was used to determine the changes between the measurements and the difference in the changes between the two groups in body weight, metabolic measurements, and fatty acid composition of serum lipds.

The changes in dietary variables between 3 and 15 months in each group were measured by paired t test.

The sample means of body weight, metabolic measurements, and the fatty acid composition of serum lipids were compared using the t test for independent samples at 15 months.

Data Collection Summary:

Timing of Measurements

All completed 4-day food records before 3, 9, and 15 mos visits

Biochemical and anthropometric data collected at 0, 3, and 15 mos.

Dependent Variables

Body weight
Fasting blood glucose
HbA1c
Serum lipids: T-chol, HDL-chol, TG
Dietary intake: kcal, protein, fat, SF, MUFA, PUFA, cholesterol, fiber

Independent Variables

all patients kept 3 sets of 4-day food records before clinic visits, but it is unclear if these were used to assess dietary adherence

Control Variables

Gender

Description of Actual Data Sample:

Initial N: 86 subjects

49 men and 37 women
40 in intervention group;46 in conventional group
25 in intervention and 19 in conventional groups were on CVD medications.

Attrition (final N): 86 subjects

Age: 50±7.7 to 54.4±6.4 years

Ethnicity: white

Other relevant demographics: no significant differences in demographics or prevalence of cardiovascular diseases between control and intervention groups.

Anthropometrics:

Men (n=21)

age: 50.7±7.7 yr

BMI: 32.6±3.9

Fasting Blood glucose 11.3±3.3 mmol/L

Women (n= 19)

age: 53.7±6.3 yr

BMI 35.3±6.7

Fasting blood glucose 11.3±5.7

Location: 5 rural and one urban clinic in Finland

Summary of Results:

	Conventional		Intervention
	Baseline	15 months	Baseline	15 months
Weight (kg)	92.2	90.2	91.6	86.5
FBG (mmol/L)	8.9	7.5*	7.6	6.2*
HbA1c (%)	9.0	7.5**	8.4	6.6**
T-chol (mmol/L)	6.5	6.4	6.3	6.0
HDL-chol (mmol/L)	1.12	1.21	1.07	1.20
TG (mmol/L)	2.88	2.33	2.76	1.96

*,**Significantly different by treatment at 15 mos *(P<0.05)**(P<0.053)

Significantly greater weight loss in the intervention group at 15 mos (P<0.05).

The mean FBG decrased significantly in both groups 0-3 mos (P<0.001) and was significantly lower in the intervention group compared to the conventional group at 15 mos. (P<0.05)

HgA1c decreased significantly in both groups 0-3 mos (P<0.001) and was lower in the intervention group compared to the conventional group at 15 mos (P<0.053)

Diet: A significantly greater proportion of the intervention group achieved the recommendations for total fat (<30% of energy) and SFA (<10% of energy)(P<0.05). About 2/3 of subjects from both groups met cholesterol goals.

Only 2 patients in the intervention group and 0 in the conventional group met fiber goals (>25 g/1000 kcal).

Mean fiber intakes were 17 g in the intervention group and 15 g in the conventional group.

Energy Intakes

	Intervention		Conventional
	3 months	15 months	3 months	15 months
Men	2080	1888	1914	2005
Women	1331	1283	1130	1214

Author Conclusion:

Even moderate energy restriction and slight changes in the amount and quality of dietary fatty acids, especially in favor of unsaturated fatty acids, can result in weight reduction and improvement in glycemic control and the serum lipid profile of patients with newly diagnosed NIDDM.

In most of these patients, good metabolic control can be achieved without drug therapy through intensive dietary intervention.

Funding Source:

Not-for-profit

Foundation associated with industry:

Reviewer Comments:

The intervention group lost more weight and had lower FBG at the end of the study period. Differences in HbA1c between groups at 15 mos nearly reached significance (P<0.053).

The conventional group received ongoing diabetes from their local clinics and received diabetes education (including diet) from the diabetes nurse at 0, 6 wk and 3 mos. Therefore, the conventional group received more education than the control groups have received in other studies.

The (RD) provided individualized counseling (and 1 group session on food preparation methods) a total of 6 times in 1 yr (1 group + 5 individual sessions).

Quality Criteria Checklist: Primary Research
Relevance Questions
	1.	Would implementing the studied intervention or procedure (if found successful) result in improved outcomes for the patients/clients/population group? (Not Applicable for some epidemiological studies)	Yes
	2.	Did the authors study an outcome (dependent variable) or topic that the patients/clients/population group would care about?	Yes
	3.	Is the focus of the intervention or procedure (independent variable) or topic of study a common issue of concern to dieteticspractice?	Yes
	4.	Is the intervention or procedure feasible? (NA for some epidemiological studies)	Yes

Validity Questions
1.	Was the research question clearly stated?		Yes
	1.1.	Was (were) the specific intervention(s) or procedure(s) [independent variable(s)] identified?	Yes
	1.2.	Was (were) the outcome(s) [dependent variable(s)] clearly indicated?	Yes
	1.3.	Were the target population and setting specified?	Yes
2.	Was the selection of study subjects/patients free from bias?		Yes
	2.1.	Were inclusion/exclusion criteria specified (e.g., risk, point in disease progression, diagnostic or prognosis criteria), and with sufficient detail and without omitting criteria critical to the study?	Yes
	2.2.	Were criteria applied equally to all study groups?	Yes
	2.3.	Were health, demographics, and other characteristics of subjects described?	Yes
	2.4.	Were the subjects/patients a representative sample of the relevant population?	Yes
3.	Were study groups comparable?		Yes
	3.1.	Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT)	Yes
	3.2.	Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline?	Yes
	3.3.	Were concurrent controls or comparisons used? (Concurrent preferred over historical control or comparison groups.)	Yes
	3.4.	If cohort study or cross-sectional study, were groups comparable on important confounding factors and/or were preexisting differences accounted for by using appropriate adjustments in statistical analysis?	N/A
	3.5.	If case control study, were potential confounding factors comparable for cases and controls? (If case series or trial with subjects serving as own control, this criterion is not applicable.)	N/A
	3.6.	If diagnostic test, was there an independent blind comparison with an appropriate reference standard (e.g., "gold standard")?	N/A
4.	Was method of handling withdrawals described?		Yes
	4.1.	Were follow-up methods described and the same for all groups?	Yes
	4.2.	Was the number, characteristics of withdrawals (i.e., dropouts, lost to follow up, attrition rate) and/or response rate (cross-sectional studies) described for each group? (Follow up goal for a strong study is 80%.)	Yes
	4.3.	Were all enrolled subjects/patients (in the original sample) accounted for?	Yes
	4.4.	Were reasons for withdrawals similar across groups?	N/A
	4.5.	If diagnostic test, was decision to perform reference test not dependent on results of test under study?	N/A
5.	Was blinding used to prevent introduction of bias?		???
	5.1.	In intervention study, were subjects, clinicians/practitioners, and investigators blinded to treatment group, as appropriate?	No
	5.2.	Were data collectors blinded for outcomes assessment? (If outcome is measured using an objective test, such as a lab value, this criterion is assumed to be met.)	Yes
	5.3.	In cohort study or cross-sectional study, were measurements of outcomes and risk factors blinded?	N/A
	5.4.	In case control study, was case definition explicit and case ascertainment not influenced by exposure status?	N/A
	5.5.	In diagnostic study, were test results blinded to patient history and other test results?	N/A
6.	Were intervention/therapeutic regimens/exposure factor or procedure and any comparison(s) described in detail? Were interveningfactors described?		Yes
	6.1.	In RCT or other intervention trial, were protocols described for all regimens studied?	Yes
	6.2.	In observational study, were interventions, study settings, and clinicians/provider described?	N/A
	6.3.	Was the intensity and duration of the intervention or exposure factor sufficient to produce a meaningful effect?	Yes
	6.4.	Was the amount of exposure and, if relevant, subject/patient compliance measured?	???
	6.5.	Were co-interventions (e.g., ancillary treatments, other therapies) described?	Yes
	6.6.	Were extra or unplanned treatments described?	Yes
	6.7.	Was the information for 6.4, 6.5, and 6.6 assessed the same way for all groups?	Yes
	6.8.	In diagnostic study, were details of test administration and replication sufficient?	N/A
7.	Were outcomes clearly defined and the measurements valid and reliable?		Yes
	7.1.	Were primary and secondary endpoints described and relevant to the question?	Yes
	7.2.	Were nutrition measures appropriate to question and outcomes of concern?	Yes
	7.3.	Was the period of follow-up long enough for important outcome(s) to occur?	Yes
	7.4.	Were the observations and measurements based on standard, valid, and reliable data collection instruments/tests/procedures?	Yes
	7.5.	Was the measurement of effect at an appropriate level of precision?	Yes
	7.6.	Were other factors accounted for (measured) that could affect outcomes?	Yes
	7.7.	Were the measurements conducted consistently across groups?	Yes
8.	Was the statistical analysis appropriate for the study design and type of outcome indicators?		Yes
	8.1.	Were statistical analyses adequately described and the results reported appropriately?	Yes
	8.2.	Were correct statistical tests used and assumptions of test not violated?	Yes
	8.3.	Were statistics reported with levels of significance and/or confidence intervals?	Yes
	8.4.	Was "intent to treat" analysis of outcomes done (and as appropriate, was there an analysis of outcomes for those maximally exposed or a dose-response analysis)?	N/A
	8.5.	Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)?	Yes
	8.6.	Was clinical significance as well as statistical significance reported?	Yes
	8.7.	If negative findings, was a power calculation reported to address type 2 error?	N/A
9.	Are conclusions supported by results with biases and limitations taken into consideration?		Yes
	9.1.	Is there a discussion of findings?	Yes
	9.2.	Are biases and study limitations identified and discussed?	Yes
10.	Is bias due to study's funding or sponsorship unlikely?		Yes
	10.1.	Were sources of funding and investigators' affiliations described?	Yes
	10.2.	Was the study free from apparent conflict of interest?	Yes